Connector Interface For ECG-Based Catheter Positioning System

ABSTRACT

A connector interface configured to enable component interconnection with a location sensor of a catheter placement system is disclosed. The catheter placement system is configured to assist a clinician in positioning a catheter in a desired location within a body of a patient. In one embodiment, the location sensor assembly comprises a location sensor body for temporary placement on a portion of the patient body, and a connector interface. The connector interface is configured to removably attach to the location sensor and provide a plurality of electrically conductive pathways between the location sensor and additional components of the catheter placement system to enable the additional components to operably connect with the location sensor. The connector interface further includes a first connector configured to operably connect with a second connector of one of the additional components of the catheter placement system through a drape interposed between the first and second connectors.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional PatentApplication No. 62/185,477, filed Jun. 26, 2015, and titled “InterfaceConnector for ECG-based Catheter Positioning System,” which isincorporated herein by reference in its entirety.

BRIEF SUMMARY

Briefly summarized, embodiments of the present invention are directed toa connector interface that is configured to enable componentinterconnection with a location sensor of a catheter placement system.The catheter placement system is configured to assist a clinician inpositioning a catheter in a desired location within a body of a patient,such as a lower ⅓^(rd) portion of the superior vena cava within thepatient's vasculature.

In one embodiment, the location sensor assembly comprises a locationsensor body for temporary placement on a portion of the patient body,and a connector interface. The connector interface is configured toremovably attach to the location sensor and provide a plurality ofelectrically conductive pathways between the location sensor andadditional components of the catheter placement system to enable theadditional components to operably connect with the location sensor. Theconnector interface further includes a first connector configured tooperably connect with a second connector of one of the additionalcomponents of the catheter placement system through a sterile barrier,such as a surgical drape, interposed between the first and secondconnectors.

These and other features of embodiments of the present invention willbecome more fully apparent from the following description and appendedclaims, or may be learned by the practice of embodiments of theinvention as set forth hereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

A more particular description of the present disclosure will be renderedby reference to specific embodiments thereof that are illustrated in theappended drawings. It is appreciated that these drawings depict onlytypical embodiments of the invention and are therefore not to beconsidered limiting of its scope. Example embodiments of the inventionwill be described and explained with additional specificity and detailthrough the use of the accompanying drawings in which:

FIG. 1 is a block diagram of a catheter placement system according toone embodiment;

FIG. 2 is a simplified view of a patient and the catheter placementsystem of FIG. 1;

FIGS. 3A-3C depict various views of a location sensor of the catheterplacement system of FIGS. 1 and 2;

FIGS. 4A-4C depict various views of a connector interface of thelocation sensor or FIGS. 3A-3C;

FIG. 5 is an end view of the location sensor of FIGS. 3A-3C;

FIG. 6 is a perspective view of a stylet of the catheter placementsystem of FIGS. 1 and 2;

FIG. 7 is a perspective view of a tether connector of the stylet of FIG.6;

FIGS. 8A and 8B depict various views of the connection of the tetherconnector of FIG. 6 with the location sensor of FIGS. 3A-3C;

FIG. 9 is a perspective view of a location sensor according to oneembodiment;

FIG. 10 is a perspective view of a connector interface for attachment tothe location sensor of FIG. 9;

FIG. 11 depicts attachment of the connector interface of FIG. 10 withthe location sensor of FIG. 9;

FIG. 12 shows a side view of a patient with the location sensor of FIG.8B placed on the patient; and

FIG. 13 is an end view of a connector interface according to oneembodiment.

DETAILED DESCRIPTION OF SELECTED EMBODIMENTS

Reference will now be made to figures wherein like structures will beprovided with like reference designations. It is understood that thedrawings are diagrammatic and schematic representations of exemplaryembodiments of the present invention, and are neither limiting nornecessarily drawn to scale.

For clarity it is to be understood that the word “proximal” refers to adirection relatively closer to a clinician using the device to bedescribed herein, while the word “distal” refers to a directionrelatively further from the clinician. For example, the end of acatheter placed within the body of a patient is considered a distal endof the catheter, while the catheter end remaining outside the body is aproximal end of the catheter. Also, the words “including,” “has,” and“having,” as used herein, including the claims, shall have the samemeaning as the word “comprising.”

Embodiments of the present disclosure are generally directed to aconnector interface connector for use in interconnecting variouselements of a catheter placement system. Use of the present interfaceconnector enables various components of the catheter placement system tobe replaced or interchanged while enabling other components to remain.This in turn reduces system cost and allows for a modular system design.

FIGS. 1 and 2 depict various details of a catheter placement system(“system” or “placement system”), generally designated at 10, whichserves as one example environment wherein embodiments of the presentdisclosure can be practiced. The system 10 is employed to assist aclinician in the placement of a catheter or other medical device withinthe body of a patient, such as within the vasculature. In oneembodiment, the system 10 enables a distal tip of a catheter to beplaced within the patient vasculature in desired proximity to the heartusing ECG signals produced by the patient's heart. In one embodiment,the medical device includes a catheter and the intended destination ofthe catheter within the patient body is such that the distal tip of thecatheter is disposed in the lower ⅓^(rd) portion of the superior venacava (“SVC”). The guidance and placement system analyzes the ECG signalsof the patient to determine when the catheter has reached its intendeddestination within the vasculature, then notifies the clinician via adisplay, for instance. Thus, the system includes an ECG modality forassisting in medical device placement within the patient.

In one embodiment, the above-referenced ECG guidance modality of thesystem 10 is accompanied by an ultrasound (“US”) modality to assist withinitial insertion of the medical device into the body, and a magneticelement-based tracking, or tip location system (“TLS”) modality to trackthe position and orientation of the medical device as it advances towardits intended destination.

As mentioned, FIGS. 1 and 2 depict various components of the system 10in accordance with one example embodiment. As shown, the system 10generally includes a console 20, display 30, probe 40, and sensor 50,each of which is described in further detail below.

FIG. 2 shows the general relation of these components to a patient 70during a procedure to place a catheter 72 into the patient vasculaturethrough a skin insertion site 73. FIG. 2 shows that the catheter 72generally includes a proximal portion 74 that remains exterior to thepatient and a distal potion 76 that resides within the patientvasculature after placement is complete. In the present embodiment, thesystem 10 is employed to ultimately position a distal tip 76A of thecatheter 72 in a desired position within the patient vasculature. In oneembodiment, the desired position for the catheter distal tip 76A isproximate the patient's heart, such as in the lower one-third (⅓^(rd))portion of the Superior Vena Cava (“SVC”). Of course, the system 10 canbe employed to place the catheter distal tip in other locations. Thecatheter proximal portion 74 further includes a bifurcation hub 74A thatprovides fluid communication between the one or more lumens of thecatheter 72, one or more extension tubes 74B extending proximally fromthe hub, and corresponding connectors 74C for enabling connection to thecatheter 72.

A processor 22, including non-volatile memory such as EEPROM forinstance, is included in the console 20 for controlling system functionduring operation of the system 10, thus acting as a control processor. Adigital controller/analog interface 24 is also included with the console20 and is in communication with both the processor 22 and other systemcomponents to govern interfacing between the probe 40, sensor 50, andother system components.

The system 10 further includes ports 52 for connection with the sensor50 and optional components 54 including a printer, storage media,keyboard, etc. The ports in one embodiment are USB ports, though otherport types or a combination of port types can be used for this and theother interfaces connections described herein. A power connection 56 isincluded with the console 20 to enable operable connection to anexternal power supply 58. An internal battery 60 can also be employed,either with or exclusive of an external power supply. Power managementcircuitry 59 is included with the digital controller/analog interface 24of the console to regulate power use and distribution.

The display 30 in the present embodiment is integrated into the console20 and is used to display information to the clinician during thecatheter placement procedure. In another embodiment, the display may beseparate from the console. As will be seen, the content depicted by thedisplay 30 changes according to which mode the catheter placement systemis in: US, TLS, or in other embodiments, ECG tip confirmation. In oneembodiment, a console button interface 32 and buttons included on theprobe 40 can be used to immediately call up a desired mode to thedisplay 30 by the clinician to assist in the placement procedure. In oneembodiment, information from multiple modes, such as TLS and ECG, may bedisplayed simultaneously. Thus, the single display 30 of the systemconsole 20 can be employed for ultrasound guidance in accessing apatient's vasculature, TLS guidance during catheter advancement throughthe vasculature, and (as in later embodiments) ECG-based confirmation ofcatheter distal tip placement with respect to a node of the patient'sheart. In one embodiment, the display 30 is an LCD device.

The probe 40 is employed in connection with the first modality mentionedabove, i.e., ultrasound (“US”)-based visualization of a vessel, such asa vein, in preparation for insertion of the catheter 72 into thevasculature. Such visualization gives real time ultrasound guidance forintroducing the catheter into the vasculature of the patient and assistsin reducing complications typically associated with such introduction,including inadvertent arterial puncture, hematoma, pneumothorax, etc.

As such, in one embodiment a clinician employs the first, US, modalityto determine a suitable insertion site and establish vascular access,such as with a needle and introducer, then with the catheter. Theclinician can then seamlessly switch, via button pushes on the probebutton pad, to the second, TLS, modality without having to reach out ofthe sterile field. The TLS mode can then be used to assist inadvancement of the catheter 72 through the vasculature toward anintended destination.

FIG. 1 shows that the probe 40 further includes button and memorycontroller 42 for governing button and probe operation. The button andmemory controller 42 can include non-volatile memory, such as EEPROM, inone embodiment. The button and memory controller 42 is in operablecommunication with a probe interface 44 of the console 20, whichincludes a piezo input/output component 44A for interfacing with theprobe piezoelectric array and a button and memory input/output component44B for interfacing with the button and memory controller 42.

Note that while a vein is typically depicted on the display 30 duringuse of the system 10 in the US modality, other body lumens or portionscan be imaged in other embodiments. Note that the US mode can besimultaneously depicted on the display 30 with other modes, such as theTLS mode or ECG mode, if desired. In addition to the visual display 30,aural information, such as beeps, tones, etc., or vibratory/motion-basedcues can also be employed by the system 10 to assist the clinicianduring catheter placement. Moreover, the buttons included on the probe40 and the console button interface 32 can be configured in a variety ofways, including the use of user input controls in addition to buttons,such as slide switches, toggle switches, electronic or touch-sensitivepads, etc. Additionally, US, TLS, and ECG activities can occursimultaneously or exclusively during use of the system 10.

As just described, the handheld ultrasound probe 40 is employed as partof the integrated catheter placement system 10 to enable USvisualization of the peripheral vasculature of a patient in preparationfor transcutaneous introduction of the catheter. In the present exampleembodiment, however, the probe is also employed to control functionalityof the TLS portion, or second modality, of the system 10 when navigatingthe catheter toward its desired destination within the vasculature asdescribed below. Again, as the probe 40 is used within the sterile fieldof the patient, this feature enables TLS functionality to be controlledentirely from within the sterile field. Thus the probe 40 is adual-purpose device, enabling convenient control of both US and TLSfunctionality of the system 10 from the sterile field. In oneembodiment, the probe can also be employed to control some or allECG-related functionality, or third modality, of the catheter placementsystem 10, as described further below.

The catheter placement system 10 further includes the second modalitymentioned above, i.e., the magnetically-based catheter TLS, or tiplocation system. The TLS enables the clinician to quickly locate andconfirm the position and/or orientation of the catheter 72, such as aperipherally-inserted central catheter (“PICC”), central venous catheter(“CVC”), or other suitable catheter or medical device, during initialplacement into and advancement through the vasculature of the patient70. Specifically, the TLS modality detects a magnetic field generated bya magnetic element-equipped tip location stylet, which is pre-loaded inone embodiment into a longitudinally defined lumen of the catheter 72,thus enabling the clinician to ascertain the general location andorientation of the catheter tip within the patient body. In oneembodiment, the magnetic assembly can be tracked using the teachings ofone or more of the following U.S. Pat. Nos. 5,775,322; 5,879,297;6,129,668; 6,216,028; and 6,263,230. The contents of the afore-mentionedU.S. patents are incorporated herein by reference in their entireties.The TLS also displays the direction in which the catheter tip ispointing, thus further assisting accurate catheter placement. The TLSfurther assists the clinician in determining when a malposition of thecatheter tip has occurred, such as in the case where the tip hasdeviated from a desired venous path into another vein.

As mentioned, the TLS utilizes a stylet 130 to enable the distal end ofthe catheter 72 to be tracked during its advancement through thevasculature. In one embodiment and as shown in FIG. 6, the stylet 130includes a proximal end 130A and a distal end 130B, with am includedhandle 136. A core wire 138 distally extends from the handle 136, and atether 134 (for operably connecting the stylet 130 to the placementsystem 10) extends proximally from the handle. A magnetic assembly isdisposed distally of the core wire 138. The magnetic assembly includesone or more magnetic elements disposed adjacent one another proximatethe stylet distal end 130B and encapsulated by tubing. In the presentembodiment, a plurality of magnetic elements is included, each elementincluding a solid, cylindrically shaped ferromagnetic stacked end-to-endwith the other magnetic elements. An adhesive tip can fill the distaltip of the tubing, distally to the magnetic elements.

Note that in other embodiments, the magnetic elements may vary from thedesign in not only shape, but also composition, number, size, magnetictype, and position in the stylet distal segment. For example, in oneembodiment, the plurality of ferromagnetic magnetic elements is replacedwith an electromagnetic assembly, such as an electromagnetic coil, whichproduces a magnetic field for detection by the sensor. Another exampleof an assembly usable here can be found in U.S. Pat. No. 5,099,845,entitled “Medical Instrument Location Means,” which is incorporatedherein by reference in its entirety. Yet other examples of styletsincluding magnetic elements that can be employed with the TLS modalitycan be found in U.S. Pat. No. 8,784,336, entitled “Stylet Apparatusesand Methods of Manufacture,” which is incorporated herein by referencein its entirety. These and other variations are therefore contemplatedby embodiments of the present invention. It should appreciated hereinthat “stylet” as used herein can include any one of a variety of devicesconfigured for removable placement within a lumen of the catheter toassist in placing a distal end of the catheter in a desired locationwithin the patient's vasculature. In one embodiment, the stylet includesa guidewire. As such, it is appreciated that stylets of other forms andconfigurations can also be acceptably used, in accordance with thepresent disclosure.

FIG. 2 shows disposal of the stylet 130 substantially within a lumen inthe catheter 72 such that the proximal portion thereof extendsproximally from the catheter lumen, through the bifurcation hub 74A andout through a selected one of the extension tubes 74B. So disposedwithin a lumen of the catheter, the distal end 130B of the stylet 130 inthe present embodiment is substantially co-terminal with the distalcatheter end 76A such that detection by the TLS of the stylet distal endcorrespondingly indicates the location of the catheter distal end. Inother embodiments, other positional relationships between the distalends of the stylet and catheter or medical device are possible.

The TLS sensor 50 (also referred to herein as a “location sensor”) isemployed by the system 10 during TLS operation to detect the magneticfield produced by the magnetic elements of the stylet 130. As seen inFIG. 2, the TLS sensor 50 is placed on the chest of the patient duringcatheter insertion. The TLS sensor 50 is positioned on the chest of thepatient in a predetermined location, such as through the use of externalbody landmarks, to enable the magnetic field of the stylet magneticelements, disposed in the catheter 72 as described above, to be detectedduring catheter transit through the patient vasculature. Again, as themagnetic elements of the stylet magnetic assembly are co-terminal withthe distal end 76A of the catheter 72 in one embodiment (FIG. 2),detection by the TLS sensor 50 of the magnetic field of the magneticelements provides information to the clinician as to the position andorientation of the catheter distal end during its transit.

In greater detail, the TLS sensor 50 is operably connected to theconsole 20 of the system 10 via a connection of a console cable 140 withone or more of the ports 52 of the console, as shown in FIG. 1. Theconsole cable 140 attaches to the TLS sensor 50 in a manner to bedescribed further below. Note that other connection schemes between theTLS sensor and the system console can also be used, without limitation.As just described, the magnetic elements are employed in the stylet 130to enable the position of the catheter distal end 76A (FIG. 2) to beobservable relative to the TLS sensor 50 placed on the patient's chest.Detection by the TLS sensor 50 of the stylet magnetic elements isgraphically displayed on the display 30 of the console 20 during TLSmode. In this way, a clinician placing the catheter is able to generallydetermine the location of the catheter distal end 76A within the patientvasculature relative to the TLS sensor 50 and detect when cathetermalposition, such as advancement of the catheter along an undesiredvein, is occurring.

As discussed above, the system 10 includes additional functionality inthe present embodiment wherein determination of the proximity of thecatheter distal tip 76A relative to a sino-atrial (“SA”) or otherelectrical impulse-emitting node of the heart of the patient 70 can bedetermined, thus providing enhanced ability to accurately place thecatheter distal tip in a desired location proximate the node. Alsoreferred to herein as “ECG” or “ECG-based tip confirmation,” this thirdmodality of the system 10 enables detection of ECG signals from the SAnode in order to place the catheter distal tip in a desired locationwithin the patient vasculature. Note that the US, TLS, and ECGmodalities are seamlessly combined in the present system 10, but can beemployed in concert or individually to assist in catheter placement. Inone embodiment, it is understood that the ECG modality as describedherein can be included in a stand-alone system without the inclusion ofthe US and TLS modalities. Thus, the environments in which theembodiments herein are described are understood as merely exampleenvironments and are not considered limiting of the present disclosure.

As described, the catheter stylet 130 is removably predisposed withinthe lumen of the catheter 72 being inserted into the patient 70 via theinsertion site 73. The stylet 130, in addition to including a magneticassembly for the magnetically-based TLS modality, includes a sensingcomponent, i.e., an internal, intravascular ECG sensor assembly,proximate its distal end and including a portion that is co-terminalwith the distal end of the catheter tip for intravascularly sensing ECGsignals produced by the SA node, in the present embodiment when thecatheter 72 and accompanying stylet 130 are disposed within the patientvasculature. The intravascular ECG sensor assembly is also referred toherein as an internal or “intravascular ECG sensor component,” and thestylet 130 as an “ECG stylet.”

As mentioned, the stylet 130 includes the tether 134 extending from itsproximal end 130A that operably connects to the TLS sensor 50 in amanner to be described below, though other connection schemes to thesystem 10 are contemplated. As will be described in further detail, thestylet tether 134 permits ECG signals detected by the ECG sensorassembly included on a distal portion of the stylet 130 to be conveyedto the TLS sensor 50 during confirmation of the catheter tip location aspart of the ECG signal-based tip confirmation modality.

External reference and ground ECG electrodes 158 attach to the body ofthe patient 70 in the present embodiment and are operably attached tothe TLS sensor 50 to provide an external baseline ECG signal to thesystem 10 and to enable the system to filter out high level electricalactivity unrelated to the electrical activity of the SA node of theheart, thus enabling the ECG-based tip confirmation functionality. Asshown, in the present embodiment, one external electrode 158 is placedon the patient skin proximate the upper right shoulder (“right arm”placement) while another external electrode is placed proximate thelower left abdomen (“left leg” placement). This electrode arrangementprovides a lead II configuration according to Einthoven's triangle ofelectrocardiography. Operable attachment of the external electrodes 158with the sensor 50 in a manner to be described below enables the ECGsignals detected by the external electrodes to be conveyed to theconsole 20 of the system 10 or to another suitable destination. As such,the external electrodes 158 serve as one example of an external ECGsensor component. Other external sensors for detecting a baseline ECGsignal external to the patient body can also be employed in otherembodiments. In addition, other electrode locations are also possible.

Together with the external ECG signal received from the external ECGsensor component (i.e., the external ECG electrodes 158 placed on thepatient's skin), an internal, intravascular ECG signal sensed by theinternal ECG sensor component (i.e., the stylet ECG sensor assembly ofthe stylet 130), is received by the TLS sensor 50 positioned on thepatient's chest (FIG. 10) or other designated component of the system10. The TLS sensor 50 and/or console processor 22 can process theexternal and internal ECG signal data to produce one or moreelectrocardiogram traces, including a series of discrete ECG complexes,on the display 30, as will be described. In the case where the TLSsensor 50 processes the external and internal ECG signal data, aprocessor is included therein to perform the intended functionality. Ifthe console 20 processes the ECG signal data, the processor 22,controller 24, or other processor can be utilized in the console toprocess the data.

Thus, as it is advanced through the patient vasculature, the catheter 72equipped with the stylet 130 as described above can advance under theTLS sensor 50, which is positioned on the chest of the patient as shownin FIG. 10. This enables the TLS sensor 50 to detect the position of themagnetic assembly of the stylet 130 (described further above), which issubstantially co-terminal with the distal tip 76A of the catheter aslocated within the patient's vasculature. The detection by the TLSsensor 50 of the stylet magnetic assembly is depicted on the display 30during ECG mode.

The display 30 can further depict during ECG mode one or more ECGelectrocardiogram traces produced as a result of patient heart'selectrical activity as detected by the external and internal ECG sensorcomponents described above. In greater detail, the ECG electricalactivity of the SA node, including the P-wave of the trace, is detectedby the external and internal sensor components and forwarded to the TLSsensor 50 and console 20. The ECG electrical activity is then processedfor depiction on the display 30, as will be described further below.

A clinician placing the catheter can then observe the ECG data, whichassists in determining optimum placement of the distal tip 76A of thecatheter 72, such as proximate the SA node, for instance. In oneembodiment, the console 20 includes the electronic components, such asthe processor 22 (FIG. 1), necessary to receive and process the signalsdetected by the external and internal sensor components. In anotherembodiment, the TLS sensor 50 can include the necessary electroniccomponents processing the ECG signals.

As already discussed, the display 30 is used to display information tothe clinician during the catheter placement procedure. The content ofthe display 30 changes according to which mode the catheter placementsystem is in: US, TLS, or ECG. Any of the three modes can be immediatelycalled up to the display 30 by the clinician, and in some casesinformation from multiple modes, such as TLS and ECG, may be displayedsimultaneously. In one embodiment, as before, the mode the system is inmay be controlled by the control buttons included on the handheld probe40, thus eliminating the need for the clinician to reach out of thesterile field (such as touching the button interface 32 of the console20) to change modes. Thus, in the present embodiment the probe 40 isemployed to also control some or all ECG-related functionality of thesystem 10. Note that the button interface 32 or other inputconfigurations can also be used to control system functionality. Also,in addition to the visual display 30, aural information, such as beeps,tones, etc., can also be employed by the system to assist the clinicianduring catheter placement.

Note that further details regarding the system 10 can be found in U.S.Pat. No. 8,848,382, issued Sep. 30, 2014, and entitled “Apparatus andDisplay Methods Relating to Intravascular Placement of a Catheter,”which is incorporated herein by reference in its entirety. It is furthernoted that the above-described catheter placement system is but exampleof a variety of placement systems that can benefit from the principlesof the embodiments described herein.

In view of the above discussion, reference is now made to FIGS. 3A-3C,which depict various details of the above-described TLS sensor 50, alsoreferred to herein as a “location sensor.” In particular, the locationsensor 50 includes a connector interface (“interface”) 1510 that isconfigured according to one embodiment. The interface 1510 is configuredto enable interconnection of the location sensor 50 with various othercatheter placement system components, including the ECG signal-sensingstylet 130 via the tether 134 (FIG. 6), the external ECG electrodes 158(FIG. 2) via their respective lead wires (“leads”), and the consolecable 140 that operably connects the location sensor with the console 20of the system 10.

As shown, the interface 1510 includes a body 1512 that is configured toremovably connect to the location sensor 50 within a pocket 1514 definedon a lower portion of the location sensor 50, from the perspective shownin FIG. 3A. The interface body 1512 includes a rail 1518 defined on afin 1520 that is configured to be slidably received within acorresponding track 1516 defined on an outer surface 50A of the locationsensor 50 proximate the pocket 1514, as shown in FIG. 3C. Otherconnective schemes can be employed in other embodiments. Also, theparticular size, shape, and configuration of the interface 1510 canvary. A bottom portion 1520A of the fin 1520 is configured to beslidably received within a track perimeter 1522 defined about the track1516 in order to secure the connection between the location sensor 50and the interface 1510.

The interface body 1512 defines an outer surface 1524 that is shaped andconfigured so as to match the outer surface 50A of the location sensor50 when the interface 1510 is attached to the location sensor. Ofcourse, the particular shape and configuration of both the locationsensor and the interface can vary from what is shown and described.Also, the particular connection point of the interface with the locationsensor can vary. The interface body 1512 further defines an end surface1528 that remains externally accessible when the interface 1510 isoperably attached to the location sensor (FIGS. 3A, 3B), as well as aninner surface 1528 (FIGS. 3C, 4B, 4C) that is inaccessible when theinterface is attached to the location sensor. As will be described,various connection points are included on both the end surface 1526 andthe inner surface 1528 to enable various components of the catheterplacement system 10 to operably connect with the location sensor 50. Thesize, shape, type, and number of connection points can vary from thebelow discussion.

FIGS. 4A-4C depict further details regarding the interface 1510. Asshown, the end surface 1526 includes various connection points forenabling interconnection with components of the catheter placementsystem 10. Specifically, the end surface 1526 includes a pair of ECGlead connector receptacles 1530 disposed in a recess 1532. The ECG leadconnector receptacles 1530 each include a female contact 1530A sized andconfigured to receive therein a male connector end of the leads of theECG electrodes 158. In the present embodiment, the recess 1532 is shapedso as to receive a dual connector that includes both male connector endsof the ECG electrodes 158 in a single plug, though other configurationsare also possible for the ECG lead connection scheme.

FIG. 4A shows that the fin 1520 includes an ECG stylet wire receptacle1542, surrounded by a centering cone 1544, for removably receivingtherein a pin contact 170 (FIG. 7) of a tether connector 132 of the ECGstylet 130 (FIG. 6). Further details regarding connection of the ECGstylet 130 to the interface 1510 and the location sensor 50 are givenfurther below.

FIG. 4A further shows that the console cable 140 is permanently attachedso as to extend from the interface 1510, as shown. The length of theconsole cable 140 can vary according to need, but is sufficient in thepresent embodiment to extend between the location sensor 50 and theconsole 20, as shown in FIG. 2.

The inner surface 1528 of the interface 1510 includes various connectionpoints for enabling interconnection of the aforementioned componentswith the location sensor. As shown, in FIGS. 4B and 4C, a USB type Bplug 1550 of the console cable 140 extends from the interface innersurface 1528 to operably connect with a corresponding USB type Breceptacle 1570 (FIG. 5) disposed in the pocket 1514 when the interface1510 mates with the location sensor 50. Similarly, a rounded,cylindrical ECG plug 1560 extends from the interface inner surface 1528to operably connect with a corresponding, cylindrically shaped ECGreceptacle 1580 defined in the pocket 1514 when the interface 1510 mateswith the location sensor 50.

Specifically, the ECG plug 1560 includes an ECG stylet wire contact1560A that is operably connected with the ECG stylet wire receptacle1542 on the fin 1520, as well as two ECG lead contacts 1560B that areoperably connected with the ECG lead electrical contacts 1530A in theECG lead receptacle 1530 included on the interface end surface 1526. Inthe present embodiment, the ECG lead contacts 1560B are integrallyformed with the ECG lead contacts 1530A and are formed as sleeves so asto receive corresponding ECG lead pins 1580B disposed in the ECGreceptacle 1580. The ECG receptacle 1580 further includes an ECG styletpin 1580A for operably connecting with the sleeve-type ECG stylet wirecontact 1560A of the ECG plug 1560. FIGS. 3A, 8A, and 8B show the mannerof attachment of the interface 1510 within the pocket 1514 of thelocation sensor 50.

FIGS. 6 and 7 show details of the ECG stylet 130, including the pincontact 170 included in a channel 172 of the tether connector 132, asdescribed further above. As shown in FIGS. 8A and 8B, the tetherconnector 132 is slid over the fin 1520 in a snug friction fit such thatthe pin contact 170 is received within the ECG stylet wire receptacle1542. The ECG stylet wire receptacle 1542 is operably connected withinthe interface body 1512 with the ECG stylet wire contact 1560A. Thus,this connection establishes an electrically conductive pathway from theECG stylet 130 to the location sensor 50 via the operable connections ofthe pin contact 170 with the ECG stylet wire receptacle 1542, and theECG stylet wire contact 1560A (FIG. 4C) of the interface 1510 with theECG stylet wire pin 1580A (FIG. 5) of the location sensor. This, inturn, enables ECG signals detected by the ECG stylet 130 to be conveyedto the location sensor 50 and, in one embodiment, the console 20 forprocessing by the system 10.

Correspondingly, FIG. 8B shows the connector ends of the leads of theECG external electrodes 158 received within the ECG lead connectorreceptacles 1530 of the interface 1510 such that they each operablyconnect with a corresponding one of the electrical contacts 1530Atherewithin. Thus, conductive pathways are established from the ECGexternal electrodes 158 to the location sensor via the operableconnections of the connector ends of the ECG external electrode leadswith ECG lead connector receptacles 1530, and the ECG lead contacts1560B (FIG. 4C) of the interface 1510 with the ECG lead pins 1580B (FIG.5) of the location sensor.

Also, conductive pathways are established from the location sensor 50 tothe console 20 (FIGS. 1, 2) via the operable connection of the consolecable 140, namely, the operable connection of its male connector 1550 ofthe interface 1510 (FIG. 4C) with the receptacle 1570 of the locationsensor (FIG. 5). Note that while shown as a USB-type cable, the consolecable can include other styles, types, form factors, etc.

In the above-described configurations, therefore, the location sensorand attached components are ready for use by the catheter placementsystem 10, in one embodiment. Indeed, FIG. 12 shows the manner of use ofthe location sensor 50 when connected with the various componentsdescribed above during a catheter insertion procedure using the catheterplacement system 10. Note that the tether connecter 132 is configured topierce a sterile drape 1600 (which is placed over the patient duringcatheter insertion procedures) such that regions above the drape areconsidered a sterile environment, while the location sensor 50, the fin1520, and the console cable 140 are not considered sterile. The mannerin which the tether connector 132 is able to pierce the drape 1600 andoperably connect with the location sensor 50 enables such a connectionwithout compromising the sterility of the sterile field.

Note that the various connecting components described with the aboveelectrically conductive connections can vary in size, type, number,etc., from what is discussed herein. Note further that in the presentembodiment attachment of the interface 1510 with the location sensor 50is maintained via the friction fit of the various electrical connectionsbetween the interface and the location sensor, as just discussed above.In another embodiment, additional features can be included on one orboth of the interface body 1512 and the location sensor 50 to provide afriction fit or other type of securement to maintain attachment betweenthe interface and the location sensor.

FIGS. 9-11 depict the interface 1510 according to another embodiment,wherein the ECG stylet wire contact 1560A and the two ECG lead contacts1560B discretely extend from interface body 1512 instead of beingincluded in a male plug (FIG. 10). Correspondingly, the ECG stylet wirepin 1580A and the two ECG lead pins 1580B of the location sensor 50 arediscretely positioned instead of grouped within a receptacle in thelocation sensor pocket 1514 (FIG. 9). Also, note that the shape andconfiguration of the track 1516 of the location sensor 50 (FIG. 9)differs from that of the previous embodiment. These and othermodifications are therefore contemplated.

FIG. 13 shows an interface connector configuration according to anotherembodiment, wherein a connector block 1660 includes not only the ECGstylet wire contact 1560A and the ECG lead contacts 1560B, but also twoelectromagnetic contacts 1660A for providing power to an electromagnetelement disposed in the ECG stylet 130 to be used when the system 10 isin TLS mode, described above. The particular arrangement andconfiguration of the various connectors can vary from what is shownhere.

It is noted that the interface 1510 in one embodiment is reusable formultiple catheter insertion procedures, but is easily removable andreplaceable should the need arise, such as in cases where damage to thewires or cables of the catheter insertion system 10 have been damageddue to use, accident, or repeated cleaning cycles. This, in turn enablesreplacement without the need to replace the entire location sensor,which can involve considerably more cost. Further, it is appreciatedthat the ECG stylet 130 and the external ECG electrodes and their leadsare disposable and are disposed of after a single catheter insertion iscomplete. The console cable in one embodiment is permanently attachedwith the interface 1510 and thus is reusable. Also, though describedhere as employed with a location sensor, the interface in otherembodiments can be employed to operably connect with other types ofmedical devices where interconnections as are enabled by the interfaceas described herein are needed. Further, note that various types ofelectrical connectors can be used to operably connect the variouscomponents described herein, including circuit board-edge connectors,peg and cuff-type connectors, type-C and other types of USB connectors,spring-loaded pins for pressing against conductive pads, etc. These andother connectors are therefore contemplated.

Embodiments of the invention may be embodied in other specific formswithout departing from the spirit of the present disclosure. Thedescribed embodiments are to be considered in all respects only asillustrative, not restrictive. The scope of the embodiments is,therefore, indicated by the appended claims rather than by the foregoingdescription. All changes that come within the meaning and range ofequivalency of the claims are to be embraced within their scope.

1. A location sensor for use with a catheter placement system, thecatheter placement system for positioning a catheter in a desiredlocation within a body of a patient, the location sensor assemblycomprising: a location sensor body for temporary placement on a portionof the patient body; and a connector interface configured to removablyattach to the location sensor, the connector interface configured toprovide a plurality of electrically conductive pathways between thelocation sensor and additional components of the catheter placementsystem to enable the additional components to operably connect with thelocation sensor, the connector interface further including a firstconnector configured to operably connect with a second connector of atleast one of the additional components of the catheter placement systemthrough a drape interposed between the first connector and the secondconnector.
 2. The location sensor as defined in claim 1, wherein theadditional components include at least one of an ECG stylet configuredto be removably disposed within a lumen of the catheter, an ECG externalelectrode, and a console of the catheter placement system.
 3. Thelocation sensor as defined in claim 1, wherein the first connectorincludes a receptacle disposed on the connector interface that isconfigured to receive the second connector included with the ECG stylet.4. The location sensor as defined in claim 3, wherein the secondconnector of the ECG stylet is a male pin connector.
 5. The locationsensor as defined in claim 4, wherein the receptacle of the firstconnector is disposed on a fin portion of the connector interface. 6.The location sensor as defined in claim 5, wherein the location sensorincludes at least one sensor configured to detect a magnetic elementincluded with the ECG stylet to assist in placing the catheter withinthe body of the patient.
 7. The location sensor as defined in claim 1,wherein the connector interface is removably received within a pocketdefined on the location sensor body.
 8. The location sensor as definedin claim 7, wherein the connector interface is disposed in the pocketvia a friction fit.
 9. The location sensor as defined in claim 8,wherein a plurality of electrical connections are defined between theconnector interface and the location sensor, the electrical connectionsproviding the friction fit of the connector interface within the pocketof the location sensor.
 10. The location sensor as defined in claim 1,wherein the drape is configured to provide a sterile barrier and whereinthe first and second connectors are configured to removably connect withone another through the drape without compromising the sterile barrierof the drape.
 11. The location sensor as defined in claim 1, wherein thelocation sensor is temporarily disposed on a chest portion of thepatient.
 12. The location as defined in claim 1, wherein during use ofthe catheter placement system, the location sensor is disposed on achest portion of the patient, the connector interface is removablyattached to a pocket defined in the location sensor, and an ECG styletis operably connected to the location sensor via the connectorinterface.
 13. The location sensor as defined in claim 12, wherein theconsole is operably connected to the location sensor via the connectorinterface and wherein a plurality of external ECG electrodes areoperably connected to the location sensor via the connector interface.14. The location sensor as defined in claim 1, wherein the connectorinterface includes a cable permanently attached thereto.
 15. Thelocation sensor as defined in claim 14, wherein the cable includes a USBcable that operably connects the location sensor to a console of thecatheter placement system.
 16. The location sensor as defined in claim1, wherein the connector interface is a replaceable component and isconfigured for use in multiple procedures to position catheters.
 17. Thelocation sensor as defined in claim 1, wherein an ECG stylet and atleast one external ECG electrode are disposable and are configured tooperably connect to the connector interface.
 18. The location sensor asdefined in claim 17, wherein electrical contacts for the ECG stylet andthe at least one external ECG electrode are disposed on a male connectorplug of the connector interface, the male connector plug configured tooperably connect with a receptacle disposed in the pocket of thelocation sensor when the connector interface operably connects with thelocation sensor.
 19. A catheter placement system for placing a catheterin a body of a patient, comprising: a system console; a location sensoroperably connected to the system console via a console cable andconfigured for temporary placement on a portion of a body of thepatient; an ECG stylet configured to be removably disposed within alumen of the catheter, and detect ECG signals when a distal portion ofthe catheter is disposed in the body of the patient, the ECG styletincluding an electrically conductive second connector; at least oneexternal ECG electrode configured to be placed on the body of thepatient; and a connector interface configured to removably attach to thelocation sensor, the connector interface configured to operablyinterconnect the console, the ECG stylet, and the at least one externalECG electrode with the location sensor, the connector interfaceincluding a first connector configured to receive the second connectorof the ECG stylet, the second connector configured to pierce a sterilebarrier disposed over the location sensor and the connector interface.20. The system as defined in claim 19, wherein the first connector ofthe connector interface includes a receptacle, wherein the secondconnector of the ECG stylet includes a pin connector, and wherein thereceptacle is configured to receive the pin connector of the ECG stylettherein, the pin contact configured to pierce the sterile barrier. 21.The system as defined in claim 20, wherein the pin connector is disposedin a channel of a tether connector body included with the ECG stylet.22. The system as defined in claim 21, wherein the receptacle isincluded on a fin that extends from a body of the connector interface,the fin including a rounded leading edge.
 23. The system as defined inclaim 19, wherein the sterile barrier includes a surgical drape.
 24. Thesystem as defined in claim 19, wherein the connector interface isremovably attachable to a pocket defined in the location sensor andwherein the connector interface enables the location sensor to receiveECG signals from the ECG stylet and from the at least one external ECGelectrode.
 25. The system as defined in claim 24, wherein a rail of theconnector interface is received within a track of the location sensorwhen the connector interface is attached within the pocket of thelocation sensor, the track including a recessed perimeter.
 26. Thesystem as defined in claim 19, wherein the connector interface includesan outer surface that matches an outer surface of the location sensorwhen the connector interface is attached to the location sensor. 27-33.(canceled)